Prosthesis for the repair of thoracic or abdominal aortic aneurysms and method therefor

ABSTRACT

An prosthesis for the repair of thoractic or abdominal aortic aneurysms (AAA) and a method for utilizing the prosthesis. Furthermore, an arrangement and method is provided for the repair of aortic aneurysms incorporating a device for the placement of the prosthesis in the corporeal lumen or body vessel of a patient, and wherein the prosthesis comprises a graft facilitating the exclusion of the aneurysm, and also provides for anastomotic structure for the attachment of the prosthesis in a laparoscopic surgical procedure.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.09/968,482, filed 28 Sep. 2001, U.S. Pat. No. 6,767,359 now allowed, thecomplete disclosure of which is hereby incorporated by reference for allpurposes.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a prosthesis for the repair of thoracicor abdominal aortic aneurysms (AAA) and to a method for utilizing theprosthesis. Furthermore, the invention is also directed to the provisionof an arrangement and method for the repair of aortic aneurysmsincorporating a device for the placement of the prosthesis in thecorporeal lumen or body vessel of a patient, and wherein the prosthesiscomprises a graft facilitating the exclusion of the aneurysm, and alsoprovides for anastomotic structure for the attachment of the prosthesisin a laparoscopic surgical procedure.

It is a well established medical fact that various fluid conducting bodyor corporeal lumens, such as veins and arteries, may deteriorate orsuffer trauma over time so that repair thereof becomes necessary. Forexample, various types of aneurysms or other deteriorative diseases mayaffect the ability of the lumen to conduct fluids, such as adequateblood flow, and in turn may create life-threatening situations. In somecases, the damaged lumen is repairable only with the use of aprosthesis, such as an artificial vessel or graft constituting areplacement vessel or a bypass.

For example, an aneurysm is a localized dilatation or weak spot in ablood vessel, whereby abdominal aortic aneurysms (AAA) are one of themost common and serious types of aneurysms. They are deemed byphysicians to be atherosclerotic in origin, in effect, related to a highfat diet, high blood pressure, and cigarette smoking, although geneticfactors that control collagen and/or elastic tissue metabolism may alsobe involved in such conditions.

In the implementation of the repair of vital vessels, such as the aorta,surgical repair is significantly life-threatening. Surgical techniqueswhich are presently known in the art involve major surgery in which agraft resembling the natural vessel is spliced into the diseased orobstructed section of the natural vessel. Known procedures includesurgically bypassing the damaged or diseased portion of the vessel andinserting an artificial or donor graft which is attached to the nativevessel by an anastomosis.

It is also known within the confines of the medical profession toprovide a prosthesis for the intraluminal repair of a vessel, such as anabdominal aorta having an aneurysm. The art has taught it to beexpedient to provide a prosthesis which is positioned in a vessel, andthen securing the prosthesis within the vessel with hooks or staplesthat are mechanically extended by the user. The early prior art deviceswere large in diameter, mechanically complex and, in turn, weresusceptible to mechanical failure. Prior intraluminal grafting systemshave embodied capsule catheters or balloon catheters, but these wererelatively stiff and of a relatively high profile. Similarly, the priorart systems were configured in such a way that the graft was relativelydifficult to deploy in the correct position. In addition, prior systemshaving a capsule catheter assembly were usually configured such that theprostheses was disposed within a unitary capsule. Further, the priorprosthesis were sometimes ill suited to withstand the high pressuresexisting in the vessels and, consequently, experienced structuralfailures.

Conventional repair of abdominal aortic aneurysms (AAA) involvesexclusion of the aneurysm by implantation of bifurcated or straightvascular prostheses via a full laparotomy. This procedure has a highmorbidity and mortality rates of 1-3%. Recent advances in engineeringhave resulted in stent-graft “prosthesis”, delivered to the aneurysm viathe femoral artery. This procedure requires a 18-24 F catheter to beplaced in the femoral artery, then worked through the iliac artery tothe aneursym, where the stent-graft is deployed. Problems associatedwith this technology include failure to exclude the aneurysm(“endoleak”), generation of microemboli as the device traversescalcified and tortuous peripheral arteries, device migration, andfrequent emergency conversions to an open surgical procedure. Anotherdifficulty associated with this technology is the need to have twodevices placed, one for the aorta-iliac and one for the contralateraliliac. This requires two arterial access sites and may increase thelikelihood of endoleak, since the junction of the aortoiliac andcontralateral iliac is not a closed seal. There have also been attemptsto repair AAA by laparoscopic techniques. This procedure may require upto 9 hours to complete, can result in paraplegia, and is also prone toemergency conversion to a laporotomy or open repair.

With regard to the prior art, although significant steps have been takento provide methods and devices for deploying intralumenally grafts andthe use of anastomotic means in order to bypass abdominal aorticaneurysms (AAA), many of these devices are still subject to difficultiesdue to utilizing catheters or extensive surgical procedures in contrastwith laparoscopic surgery which replaces the highly invasive proceduresof open surgery which are subjective to high mortality rates especiallyfor elderly and seriously-ill patients.

2. Discussion of the Prior Art

Quiachon et al., U.S. Pat. No. 6,039,758 and U.S. Pat. No. 5,628,783disclose bifurcated vessel grafts with spring-hook attachment structureat an end portion thereof, employed for a method of repairing ananeurysm in a vessel at a remote location. This necessitates the use ofcatheters and extensive surgery wherein a separate vessel engagingmembers are preattached to the graft but which do not contemplate theunique anastomotic devices attached to the graft prior to theemplacement of the prosthesis as described by the present invention.

Pierce, U.S. Pat. No. 6,152,956 discloses an endovascular prosthesis forrepair of abdominal aortic aneurysms (AAA), and which includes a graftwith an elastic wire means for connecting an end portion of the graft tothe wall of the aorta.

McNamara et al., U.S. Pat. No. 6,004,347 discloses a fabric graft with aresilient anchor structure located at the end portions of the graftrepairing an abdominal aortic aneurysm. A catheter-like a device whichincludes a dilator is provided to deploy the graft. This clearlyprecludes the utilization of laparoscopic surgery which also avoids thenecessary for open surgery potentially leading to higher patientmortality rates.

Chin, U.S. Pat. No. 5,800,540 discloses a method and an apparatus forimplementing endoscopic grafting; however, the patent does not disclosea graft including the novel anastomotic attachments at the ends of thegraft and the unique system for the emplacement thereof.

Pinchuk et al., U.S. Pat. No. 5,700,269 discloses an endoluminalprosthesis deployment device which includes a dilator tip and a plunger.Again, as in the previously described publications, there is nodisclosure of the unique prosthesis for the repair of thoracic orabdominal aorta aneurysms in a laparoscopic procedure and the uniquedevice for the emplacement of the prosthesis.

Chuter, U.S. Pat. No. 5,456,713 discloses a graft prosthesis which isequipped with anchoring barbs on the end portions thereof, andincorporates apparatus for positioning the graft within a vessel lumenin order to repair an aneurysm. However, as in the previously describedpublications, there is no disclosure of the unique auastomoticstructures which are attached to the opposite ends of the graft andwhich will enable the simple laproscopic emplacement thereof in thelumen of a patient for the repair of either a thoracic or abdominalaortic aneurysms.

European Patent Application Nos. EP 108666482; EP 1086663 A1; and EP1086665 A1 are each directed to various types of apparatus or stents,wherein the apparatus is adapted to deliver and emplace a prosthesis,and wherein a tubular graft is formed over monofilament fibers havingresilient portions for engaging the wall of the lumen.

In summation, none of the foregoing publications are adapted to providethe particular inventive prosthesis or system for the emplacementthereof in order to assist laproscopically in the repair of thoracic orabdominal aortic aneurysms.

SUMMARY OF THE INVENTION

The invention described herein involves a modification of an prosthesisby attaching anastomotic staples at each end of a graft, whereby nostent is required and no suturing is necessary, while the device can bedelivered laparoscopically in a significantly shorter time period.Anastomotic staples comprised of shape memory metals or other suitablemetals and alloys can be inserted through the distal ends of the graft,the graft everted over the staples, and the procedure completed byend-to-side anastomoses of the aorta and iliac arteries. Since theentire graft can be inserted in one piece, a second device to cover thecontralateral iliac artery is not necessary.

In particular, as disclosed by an exemplary embodiment, the presentinvention is directed to an medical device comprising a vascularprosthesis which is a bifurcated aorta-iliac prosthesis having one endconnected to the aorta, and lower or iliac branches leading awaytherefrom, with all ends of the vascular prosthesis being coupled toanastomosis devices. The graft-anastomosis device would belaparoscopically placed.

The inventive system which is utilized to repair aortic aneurysms isconstituted essentially of a device which includes:

-   -   (a) A vascular prosthesis selectively comprised of textile,        expanded PTFE, polyurethane, and other materials known to those        skilled in the art of manufacturing vascular prostheses; with        the prosthesis being configured as either a bifurcated or        straight graft depending upon intended emplacement;    -   (b) Anastomotic coupling means attached to each end of the        vascular prosthesis; with the coupling means being an annular        member made from shape memory metal or a suture-based device;    -   (c) A device for providing visualization; with the device being        comprised of insufflation means and a light source;    -   (d) A catheter, trocar, or other delivery instrument designed to        contain the graft-anastomotic device in an undeployed state;        deliver the graft-anastomotic device laparoscopically to the        desired site of anastomoses with the aorta or iliac artery; and        then deploy the graft-anastomotic device so that the aneurysm        can be repaired; and    -   (e) A vascular clamp, clip, or ligating suture such as Ligaclip™        adapted to exclude the aneurysm from blood flow after the        aneurysm has been repaired.

The method which is utilized to repair the aneurysm and employing theabove-mentioned system, includes:

-   -   (a) Providing a device for repairing an aortic aneurysm        consisting of a vascular prosthesis precoupled to an anastomotic        coupler or plurality of staples; with the device being housed in        an undeployed state within a delivery means; such delivery means        being a catheter or trocar;    -   (b) Creating at least one opening in a patient to obtain access        to the abdominal, thoracic, or retroperitoneal space within the        patient;    -   (c) Inserting the device referred to above into the patient; and    -   (d) Repairing the aneurysm by connecting the vascular graft with        anastomotic means to native vessels and clamping or ligating the        aorta at at least one site distal to the most proximal        anastomosis to exclude the aneurysm.

Accordingly, it is a primary object of the present invention to providea system for repairing an aneurysm in a body vessel through thelaparoscopic emplacement of an prosthesis consisting of a graft havinganastomostic staples at each end thereof so as to obviate the need forstenting or suturing the affected body vessel.

Another object of the invention resides in the provision of a system forrepairing an aneurysm in a body vessel through the emplacement of agraft having anastomostic staples at the ends thereof so as to obviatethe need for stenting or suturing the affected body vessel.

Yet another object of the invention is to provide a device forlaparoscopically emplacing an prosthesis in accordance with the systemand method of repairing an aneurysm as described herein.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

Reference may now be made to the following detailed description ofpreferred embodiments of the invention, taken in conjunction with theaccompany drawings; in which:

FIG. 1A illustrates, generally diagrammatically, a bifurcatedaorta-iliac vascular prosthesis or graft;

FIG. 1B illustrates a straight vascular prosthesis or graft;

FIG. 2 illustrates an anastomotic coupler adapted to be utilized ateither end of the vascular prosthesis or graft;

FIG. 3 illustrates the upper end of the graft connected to the wall ofthe aorta having the anastomotic coupler positioned on the vasculargraft or prosthesis, which coupler has been attached to the everted endof the vascular prosthesis;

FIG. 4 illustrates, generally diagrammatically, a delivery system anddevice for the emplacement of the prosthesis of FIG. 1A; and

FIG. 5 illustrates, generally schematically, a representation of theendoprosthseis in the form of a bifurcated graft as in FIG. 1A, havingbeen emplaced in order to repair an abdominal aortic aneurysm in apatient.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Reverting specifically to FIG. 1A of the drawings, there is disclosed agraft or prosthesis 10 which, in this embodiment, is a bifurcatedaorta-iliac vascular prosthesis having an upper segment 12 which is anaortic junction which faces the direction of incoming blood flow fromthe aorta, wherein the bifurcated lower end of the prosthesis 10 whichis connected to the aorta segment 12 includes left and right iliacbranches 14 and 16. This graft 10 may be readily constituted from aflexible material, such as for example, a textile, PTFE, biologicalmaterials, polyurethane, or hybrids thereof, as is widely known in theart of producing vascular prostheses.

The vascular graft or prosthesis of FIG. 1B of the drawings is similarto that of FIG. 1A; however, in this embodiment, the graft 18 isessentially tubular in nature. The materials which may be employed forthis graft 18 are basically the same as those employed for thebifurcated graft 10.

As illustrated in FIG. 2 of the drawings, there is diagrammaticallyshown a perspective view of an anastomotic coupler 20 which includes atubularly shaped structure 22 consisting of cells 24 which allow forradial expansion and forming a compliant annular body. Preferably, theconstruction thereof is constituted of a shape memory metal or alloymaterial, such as stainless steel, nitinol (nickel-titanium alloy) orsimilar material, as is well known in the art. Moreover, the couplerbody structure 22 can be formed of a suture-based device rather than ashape memory alloy. Attached to the opposite ends 24,26 of the annularcompliant body 22 are vessel or graft engaging elements, such as axiallyand outwardly bent staples 28,30 which are spaced around the peripheryof the body structure 22. These staples 28,30, may be constituted ofnitinol, or of any suitable shape memory alloy material.

FIG. 3 of the drawings illustrates the upper end portion 32 of thevascular graft or endoprostheses 10 (or 18) with the anastomotic coupler20 positioned thereover and having the end of the graft everted suchthat the staples 28 at the one end 24 of the coupler 20 pierceengagingly through the graft and the wall of the aorta 36, whereas theother staples 30 below the everted upper end portion of the graft areadapted engage into the wall of the body vessel.

The foregoing construction is also applicable to similar anastomoticcouplers which are attached to the lower ends of, respectively the twoiliac branches of the graft or prosthesis, as in FIG. 1A, or the lowerend of the tubular vascular prosthesis or graft, as in FIG. 1B.

As illustrated in FIG. 4 of the drawings, this is schematically shown adelivery system and device 40 for emplacement of the graft 10. Theprosthesis delivery device includes an essentially hollow tubular orcylindrical syringe-like or catheter member 41 having an axially movablehandle 42 for pushing or deploying the device in the body vessel, with arod member 43 extending towards the upper end of member 41 intoengagement with the aortic anastomotic coupler 20, the staples 28 ofwhich engage the wall of the aorta 36. Upon pushing the handle 42 intothe cylindrical member 42 the entire prosthesis 10 located therein is bymeans of the rod member 43 deployed into the body vessel towards asurgical incision formed in the aorta for suitable emplacement.

As shown in FIG. 5, the upper end of the aortic anastomotic coupler 20has the staples 28 engage into the aortic wall structure 36, whereas thelower bifurcated ends 14,16 of the vascular prosthesis is engaged into,respectively, the left and right iliac branches by means of iliacanastomotic couplers 50,52 which are essentially similar in constructionto the aortic anastomotic coupler 20, although understandably ofsomewhat smaller sized diameters.

As shown in FIG. 5, the delivery system 40 of FIG. 4 is introducedthrough the wall 56 of a patient's body into the abdominal cavity 58,with a laparoscopic instrument and light source 60 extending towards theregion of an aneurysm, and a further instrument and light source 62extending into the region proximate the iliac anastomotic couplers50,52.

The two laparoscopic instruments with light sources 60,62 which,respectively, are adapted to provide access to the aortic anastomoticcoupler 20 and to the iliac anastomotic couplers 50,52 require only verysmall incisions to be formed in the body of the patient. This is alsoapplicable to the incision required for the relatively small-sizeddelivery system or instrument 40 which includes the entire prosthesis,in effect; the preassembled graft 10 with the aortic and iliacanastomotic couplers 20,50,52 having all be previously attached to thegraft body. Other laparoscopic instruments such as scissors, forceps,clamps, and clips can be used to assist in attaching the prosthesis tothe aorta. Thus, it becomes readily apparent to one of skill in the art,that through the utilization a single system and delivery device it ispossible to laparoscopically emplace or deploy an entire graft 10 (or18) and anastomotic means preattached thereto in one piece, and inessentially a single procedure.

Although the foregoing description focuses on the use of the anastomosissystem in thoraco-abdominal vascular surgery, the system is equallyapplicable to other situations which may require vessel anastomosis,including, but not limited to renal artery bypass grafting,femoral-femoral bypass and arterio-venous shunting, such as is commonlyused for dialysis. Surgical anastomoses are also performed for variousreasons on many different tubular organs of the body other than bloodvessels, including the bowel, intestines, stomach and esophagus. Whilethe devices and methods of the present invention are described herein asbeing intended primarily for vascular anastomoses, some or all of theembodiments could also be modified for performing end-to-sideanastomoses on other tubular organs. Any one of the one or two-pieceembodiments of the anastomosis staple device can be supplied preattachedto a prosthetic graft vessel. For instance, the two-piece anastomosisstaple device could be supplied in a kit, including a natural orartificial graft that is prepared with an anastomotic coupling memberattached to one or both ends thereof, and one or two anchor members forattachment to the target vessel(s). Likewise, the one-piece anastomosisstaple device can be supplied in a procedural kit preattached to aprosthetic graft vessel. This is equally applicable to artificial graftmaterials, such PTFE or Dacron (registered ™) grafts, or to naturalbiological graft materials; including allografts of human graft vessels,or xenografts such as bovine or porcine graft vessels, either freshlyharvested, glutaraldehyde treated or cryogenically preserved. Ananastomotic device application or deployment instrument, such as thosedescribed above, could also be supplied in the procedural kit with oneof the anastomotic devices already attached to the distal end of theinstrument.

While the invention has been particularly shown and described withrespect to preferred embodiments thereof, it will be understood by thoseskilled in the art that the foregoing and other changes in form anddetails may be made therein without departing from the spirit and scopeof the invention.

1. A prosthesis for the extravascular endoscopic or laparoscopic repairof thoracic or abdominal aortic aneurysms; comprising: a graft memberconstituting a vascular prosthesis having respectively opposite ends,and anastomotic coupling means attached to each of the respectivelyopposite ends of said graft member, each said anastomotic coupling meansincluding anastomotic staples, at least portions of said anastomoticstaples forming vessel or graft member engaging elements extendingthrough the wall of said vessel or graft member, wherein an end portionof the graft member is inserted into said anastomotic coupling means andeverted over said anastomotic staples into engagement therewith, a firstset of the anastomotic staples engagingly piercing through the graftmember and wall of the vessel and a second set of the staples below theeverted end of the graft member engaging into the wall of the vessel,whereby said prosthesis is unitarily deployable in a corporeal lumen ofa patient so as to exclude the aneurysm.
 2. A prosthesis as claimed inclaim 1, wherein each said anastomotic coupling means comprises anannular member constituted of a shape memory metal.
 3. A prosthesis asclaimed in claim 1, wherein each said anastomotic coupling means is of acell-like structure facilitating radial expansion thereof.
 4. Aprosthesis as claimed in claim 1, wherein said graft member comprises atubular element selected from the group of materials consisting oftextiles, expanded PTFE, biological materials, polyurethane, and hybridsthereof.
 5. A prosthesis as claimed in claim 1, wherein said vascularprosthesis is a straight tubular prosthesis.
 6. A prosthesis as claimedin claim 1, wherein delivery means contains pre-assembled graft memberand anastomotic coupling means in an undeployed state preceding deliveryof the vascular prosthesis to a required site of anastomosis with anaorta or iliac artery of a patient, said delivery means maintaining saidprosthesis in readiness for deployment for the laparoscopic orendoscopic repair of an aneurysm.
 7. A prosthesis as claimed in claim 6,herein said delivery means comprises a syringe structure housing theundeployed vascular prosthesis, and axially movable pusher means forcontacting said prosthesis for emplacement of the prosthesis at a sitefor the repair of an aneurysm.
 8. A prosthesis as claimed in claim 6,wherein said delivery means comprises a deploying rod connected to aleading end of said prosthesis for deploying the prosthesis in the bodycavity of a patient.
 9. A prosthesis as claimed in claim 6, wherein saiddelivery means includes insufflation structure, at least one surgicalinstrument, and a light source for visualization of the aneurysm repairsite.